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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Argus Health
US Army

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065171

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NDA 065171 describes DEMECLOCYCLINE HYDROCHLORIDE, which is a drug marketed by Akorn, Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in five NDAs. It is available from eleven suppliers. Additional details are available on the DEMECLOCYCLINE HYDROCHLORIDE profile page.

The generic ingredient in DEMECLOCYCLINE HYDROCHLORIDE is demeclocycline hydrochloride. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the demeclocycline hydrochloride profile page.

Summary for 065171

Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for NDA: 065171


Medical Subject Heading (MeSH) Categories for 065171

Suppliers and Packaging for NDA: 065171

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065171 ANDA Teva Pharmaceuticals USA, Inc. 0555-0701 0555-0701-02 100 TABLET, FILM COATED in 1 BOTTLE (0555-0701-02)
DEMECLOCYCLINE HYDROCHLORIDE demeclocycline hydrochloride TABLET;ORAL 065171 ANDA Teva Pharmaceuticals USA, Inc. 0555-0702 0555-0702-84 48 TABLET, FILM COATED in 1 BOTTLE (0555-0702-84)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Dec 13, 2004TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Dec 13, 2004TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Queensland Health
Express Scripts

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